Optimization of Time Parameters of Priming iTBS for Poststroke Motor Rehabilitation

Last updated: January 3, 2026
Sponsor: The Hong Kong Polytechnic University
Overall Status: Completed

Phase

N/A

Condition

Stroke

Cerebral Ischemia

Treatment

continuous theta burst stimulation (cTBS)

Robot-assisted training

Robot-assisted training

Clinical Study ID

NCT06612437
HSEARS20240229006
  • Ages 18-75
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The goal of this clinical trial is to identify the effect of different time intervals between continuous theta burst stimulation (cTBS) and intermittent theta burst stimulation(iTBS), on top of a standard robot-assisted training (RAT) for sensorimotor rehabilitation in patients with chronic stroke. Using electroencephalography (EEG) to explore potential sensorimotor neuroplasticity underying stroke.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. diagnosis of hemorrhagic or ischemic stroke using computed tomography (CT) ormagnetic resonance imaging (MRI).

  2. the first-ever stroke with unilateral hemiplegia.

  3. 18-75 years old.

  4. chronic stroke ( ≥ 6 months).

  5. residual hemiparetic upper limb functional level in the Functional Test for theHemiplegic Upper Extremity (FTHUE-HK) ≥ 2.

  6. can understand and read Chinese.

  7. signed informed consent.

Exclusion

Exclusion Criteria:

  1. diagnosis of any clinically significant or unstable medical disorder.

  2. any contraindications to TMS based on the TMS safety guidelines (Rossi, Hallett,Rossini, & Pascual-Leone, 2011).

  3. inability to follow treatment instructions due to severe cognitive (using the HongKong version of the Montreal Cognitive Assessment (MoCA-HK) < 22/30) andcommunication deficiency.

  4. extreme spasticity over the hemiparetic upper limb (Modified AshworthScore>2) or severe pain that hindered movement.

  5. a history of neurological or psychiatric disease excluding stroke, or current use ofpsychoactive medication (sedatives, antipsychotics, antidepressants, etc.).

Study Design

Total Participants: 62
Treatment Group(s): 5
Primary Treatment: continuous theta burst stimulation (cTBS)
Phase:
Study Start date:
October 01, 2024
Estimated Completion Date:
December 01, 2025

Study Description

Delivering Intermittent theta burst stimulation (iTBS) primed with continuous theta burst stimulation (cTBS) to the primary motor cortex (M1) may enhance the facilitatory effect of iTBS on the stimulated M1 through metaplasticity. Previous studies have verified the effectiveness of priming iTBS on improving motor rehabilitation in patients with stroke. However, the optimal time interval between cTBS and iTBS remains unknown. The aim of this clinical trial is to identify the effect of different time intervals between cTBS and iTBS, followed with a standard robot-assisted training (RAT) for sensorimotor rehabilitation in patients with chronic stroke. Using electroencephalography (EEG) to explore potential sensorimotor neuroplasticity. A three-arm randomized controlled trial (RCT) will be performed with an estimated total of 30 patients with chronic stroke. All participants will be randomly allocated to receive 10-session intervention of different TBS protocols (i.e., cTBS-3min interval-iTBS, cTBS-10min interval-iTBS and cTBS-20min interval-iTBS), delivered for 2-4 sessions per week, lasting for 3-4 weeks. All participants will receive a 20-minute standard RAT after each stimulation session. Primary outcome will be Fugl-Meyer Assessment-Upper Extremity scores (FMA-UE). Secondary outcomes will be Action Research Arm Test (ARAT), kinematic outcomes generated during RAT as well as EEG.

Connect with a study center

  • The Hong Kong Polytechnic University

    Hong Kong, HK
    Hong Kong

    Site Not Available

  • The Hong Kong Polytechnic University

    Hong Kong 1819729, HK
    Hong Kong

    Site Not Available

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